FDA clearance for Magentiq Eye’s AI-aided colonoscopy system ‘only the tip of the iceberg’
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The FDA granted 510(k) clearance to Magentiq Eye’s artificial intelligence-aided software for real-time detection of gastrointestinal lesions during colonoscopy, according to a company press release.
The Magentiq-Colo software is intended to aid physicians by significantly improving the adenoma detection rate during colonoscopies through the use of AI/machine learning algorithms, as well as enhance the overall quality of the exam.
“FDA clearance is a major milestone, and we are very proud to join only a handful of companies in the field of AI-aided colonoscopy to be granted clearance,” Dror Zur, founder and CEO of Magentiq-Eye, said in a press release. “Our next step will be to pursue opportunities in the U.S. market as we look forward to increasing the accuracy of detecting early signs of [colorectal cancer] and taking part in saving the lives of thousands of Americans.”
The FDA based its clearance on a randomized, controlled trial of 950 patients across 10 medical centers in Europe, the U.S. and Israel, with 29 endoscopy experts, which validated Magentiq-Colo as “one of the best performing artificial intelligence solutions in the category,” according to the release.
The company reported that use of the Magentiq-Colo device improved “ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality.”
Having already received the European CE Mark and Israel AMAR approval in 2021, FDA 510(k) clearance will open the device to marketing in “one of the most significant markets for this category of medical devices,” the company noted.
“Although the sense of accomplishment is strong, I believe this is only the tip of the iceberg for AI in gastroenterology, so stay tuned for new products and features from us coming soon,” Zur said in the release.
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